Tag Archives: Immuno Concepts

July 2023—Immuno Concepts announced FDA 510(k) clearance of its IgG Anti-nDNA fluorescent test system for use with the company’s Image Navigator system. The test is for in vitro diagnostic use for qualitative detection and semiquantitation of anti-nDNA antibodies of the IgG class in human serum to aid in diagnosing systemic lupus erythematosus in conjunction with other clinical and laboratory findings.

September 2016—Immuno Concepts announced that its Image Navigator automated microscope received 510(k) clearance. Image Navigator is a software program that controls a high-quality LED fluorescent microscope with a motorized stage to simplify and organize indirect fluorescent antibody testing.